Fungiplex® Aspergillus IVD PCR

Invasive Aspergillosis
Invasive Aspergillosis (IA) is a life-threatening condition that affects immuno-compromised patients, such as those undergoing hematopoietic stem cell transplantation. Difficult to diagnose, IA is associated with high mortality. Rapid, reliable diagnostic tests for Aspergillus, when incorporated into patient care pathways, allow for the targeted use of antifungal therapy.

Clinical problem
Traditional diagnostic techniques, such as culture and histology, have poor clinical sensitivity and tend towards positivity late in disease. Delays in diagnosis by conventional techniques have led to the widespread use of prophylaxis and empiric treatment in the management of IA.
Rapid, reliable diagnostics support physicians in the timely treatment of patients with appropriate therapy, reducing the use of antifungal drugs without adversely affecting patient outcomes.¹, ²
- IA is hard to diagnose with non-specific symptoms and poor culture sensitivity.
- Delayed diagnosis is associated with high mortality and morbidity.
- The use of prophylaxis and empiric treatment is widespread.
1. Barnes RA et al. 2009 J. Clin. Pathol. 62: 64-60. doi: 10.1136/jcp.2008.058354
2. Morrissey CO et al. 2013 Lancet Infect. Dis. 13: 519-528. doi: 10.1016/S1473-3099(13)70076-8

Molecular testing for Aspergillus
Low sensitivity and slow time to result due to culture methods lead to poor clinical outcomes with traditional methods. Implementing rapid, culture free diagnostic PCR methods improves patient outcomes.
The Fungiplex® Aspergillus IVD PCR Kit is a real-time PCR designed to detect the main species associated with IA, and differentiates species resistant to first-line treatment:
- Aspergillus spp. (A. fumigatus, A. flavus, A. niger)
- A. terreus.

Rapid results
The Fungiplex® Aspergillus IVD PCR Kit provides results in under 2 hours from extracted DNA, helping the laboratory support clinical decision-making when time matters.
The inclusion of real-time PCR in regular biomarker testing strategies for the diagnosis of IA can reduce the time to diagnosis, reduce the use of empiric therapy and ultimately, reduce the cost of care.

Direct Testing
The Fungiplex® Aspergillus IVD PCR Kit is suitable for the routine testing of patients at risk of IA, and is compatible with samples taken for other biomarker tests:
- Validated on DNA extracted from whole blood, serum, plasma
- Validated on DNA extracted from bronchoalveolar lavage (BAL) fluid.

Compatibility
The Fungiplex® Aspergillus IVD PCR Kit is provided in an easy to use master-mix format and is designed to run on existing laboratory equipment, minimizing the need for dedicated bench space or additional training:
- ABI 7500
- ABI QuantStudio 5
- Bio-Rad CFX
- Hain FluoroCycler® XT
- Mic qPCR Cycler
- Roche Lightcycler 480 II
- Qiagen RotorGene.

More information
Fungiplex® Aspergillus IVD PCR (Brochure)
Expert insight - Case Study Aspergillosis
ungiplex® Aspergillus Instructions for Use